MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC ACE + 7; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number HARH45

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # p91p50.The analysis results found that the harh45 device was returned inside its package unopened.Upon visual inspection, it was observed that the blister from the packaging was damaged; the blister was found to be broken at one of the sides of the package.In, addition, the piece of the broken blister was still attached to the tyvek.Due to the damages found on the packaging and the device, a possible cause for this condition is due to improper handling during transit or storage; it appears that the package hit a hard surface and this caused the reported event.All ees product is 100% inspected prior to release.The information you provided is compiled monitored and reviewed on a routine basis for any associated trends.The lot history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.

Event Description

It was reported that before an unspecified thoracic procedure the customer found that one of the corners on the plastic packaging was cracked before opening the product.Procedure was completed with another device of the same product code.There were no patient consequences reported.

• Brand Name: HARMONIC ACE + 7
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo PR 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 00969
• Manufacturer Contact: milton garrett ; 4545 creek road ml 120a; cincinnati, OH 45242 ; 5133378865
• MDR Report Key: 6789573
• MDR Text Key: 82692917
• Report Number: 3005075853-2017-04063
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132612
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: HARH45
• Device Lot Number: P91P50
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1